K831046 is an FDA 510(k) clearance for the ELECTRODE 3799. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on April 26, 1983, 26 days after receiving the submission on March 31, 1983.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K831046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1983 |
| Decision Date | April 26, 1983 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |